The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis

Ankylosing Spondylitis (AS) Clinical Trial

Official title:

The Colonic Microbiome and Mucosal Immunity in Inflammatory Bowel Disease and Ankylosing Spondylitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02389075
• Other study ID #: 14-1507
• Secondary ID: UL1TR001082
• Status: Active, not recruiting
• Start date: March 2015
• Est. completion date: October 2026

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study plans to learn more about the relationship between systemic autoimmune disease, such as inflammatory bowel disease and ankylosing spondyloarthritis, bacteria in the colon, and the changes in colon tissue.

Description:

Changes in human gut bacteria has been shown in patients with autoimmune diseases, such as inflammatory bowel diseases (IBD). The gut flora in ankylosing spondylitis (AS), an arthritis that can occur with IBD, has not been well studied. The immune cells in the colon directly interface with bacteria and may be influenced by them. The interactions between the colon immune system, bacteria and autoimmunity hasn't been studied. The study goal is to specifically study the link between bacteria, the colonic immune system, and the autoimmune diseases of AS and IBD. This will be done by collecting clinical data by questionnaires, blood samples, colonic tissue during endoscopy, and microbiome data in subjects with IBD, AS, and controls.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Healthy Controls

Exclusion criteria:

• Pregnancy
• Use of antibiotics within the past 14 days†
• Current diagnosis of colon cancer
• Diagnosis of celiac disease
• Diagnosis of any other rheumatologic disease such as RA, SLE, etc.
• Chemotherapy or radiation therapy for any malignancy within the past year
• Daily use of aspirin or NSAIDs with inability to hold the drug 7 days before and after the procedure
• Current use of anticoagulation (LMWH,warfarin,etc.)
• A diagnosis of HIV
• Clostridium difficile within the past 3 months IBD

Inclusion Criteria:

• Established IBD (either Crohn's disease or ulcerative colitis)
• Suspected to have IBD by a gastroenterologist and undergoing diagnostic endoscopy and biopsy. Diagnosis will be confirmed on biopsy and patients who are negative will be considered for controls based on the pathology found.

Exclusion Criteria:

• Pregnancy
• Use of antibiotics within the past 14 days
• Current diagnosis of colon cancer
• Diagnosis of celiac disease
• Diagnosis of any other rheumatologic disease such as RA, SLE, etc.
• Chemotherapy or radiation therapy for any malignancy within the past year
• Daily use of aspirin or NSAIDs with inability to hold the drug 7 days before and after the procedure
• Current use of anticoagulation (LMWH, warfarin,etc.)
• A diagnosis of HIV
• Clostridium difficile within the past 3 months
• Evidence of inflammatory spinal or axial arthritis or disease based on chart review such as inflammation seen on radiographs or a diagnosis of sacroiliitis AS:

Inclusion Criteria:

• Diagnosed with an axial spondyloarthritis (SpA) by a rheumatologist -
• Meet the Assessment of SpondyloArthritis international Society (ASAS) axial spondyloarthritis (SpA) criteria

Exclusion criteria:

• Pregnancy
• Use of antibiotics within the past 14 days
• Current diagnosis of colon cancer
• Diagnosis of celiac disease
• Diagnosis of any other rheumatologic disease such as RA, SLE, etc.
• Chemotherapy or radiation therapy for any malignancy within the past year
• Daily use of aspirin or NSAIDs with inability to hold the drug 7 days before and after the procedure
• Current use of anticoagulation (LMWH,warfarin,etc.)
• A diagnosis of HIV
• Clostridium difficile within the past 3 months
• A known history of idiopathic macroscopic or microscopic colitis

Related Conditions & MeSH terms

• Ankylosing Spondylitis (AS)
• Inflammatory Bowel Diseases
• Inflammatory Bowel Diseases (IBD)
• Intestinal Diseases
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Procedure:
• Pinch biopsies
Biopsies obtained during colonoscopy or flexible sigmoidoscopy.
• Flexible sigmoidoscopy
Offered to subjects with ankylosing spondylitis who do not meet criteria for colonoscopy

Locations

Country	Name	City	State
United States	University of Colorado	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IEL characteristics in IBD, AS, and healthy controls	The primary goal for this measure will be to demonstrate characteristics of IEL (intraepithelial lymphocytes) subtypes of healthy individuals and compare those with AS or IBD. IEL characteristics will be based on cell marker outcomes using flow cytometry for CD3, CD4, CD8a, CD8ß, CD44, CD45, CD62L, CD69, CD103, TCRaß, and TCR?d.	1 hour after colonoscopy
Secondary	Microbiome Differences in IBD, AS, and healthy controls	The primary hypothesis is that the microbiome population will differ between controls, IBD, and AS; outcomes for this hypothesis will include relative abundance (RA) of individual bacterial species and the Shannon Index for community diversity.	1 hour after colonoscopy
Secondary	Microbiome changes are reflected in IELs	The primary hypothesis is that dysbiosis will be reflected in the IEL populations in AS and IBD by having a different predominant phenotype (as seen by cell markers) compared to healthy controls; the investigators will evaluate the IEL outcomes determined to be significantly different among AS, IBD, and healthy controls as identified in Outcome 1 (Primary Outcome).	1 hour after colonoscopy